Regulatory Outlook
Medical Device Makers Can Learn Social Media Skills from Pharma
Jun 14, 2011
With the emergence of interactive, real-time Internet communication and social networks, medical device companies now have access to new methods for engaging...
How to Handle a Medical Device Recall
May 13, 2011
Product recalls are challenging for any manufacturer, but when it comes to medical devices and life sciences, speed is of the essence. Any delay in a product...
Exporting Medical Devices to Europe and Emerging Markets: A Double-Edged Sword?
May 04, 2011
By requiring mandatory CE marking, the Medical Device Directive 93/42/EEC has greatly contributed to the harmonization of regulatory requirements in the 27 EU...
Applying Risk Strategies to Implantable Devices
Feb 23, 2011
Risk evaluation and mitigation strategy (REMS) is a regulatory technique implemented by FDA to ensure that the benefits of a specific drug outweigh its...
The MedSun Strategy for Manufacturers
Oct 20, 2010
DeRisio FDA launched the Medical Device Safety Network (MedSun) in 2002 as a supplement to mandatory and voluntary MedWatch reporting. Currently...
A New Era in FDA Recall Authority
Oct 01, 2010
Hills Bhatt A recall is defined as a “firm’s voluntary removal or correction of a marketed product that FDA considers to be in violation...
Deciphering De Novo Reviews
Sep 01, 2010
Ladin Imhoff Medical device manufacturers interested in marketing their products in the United States are required to secure FDA marketing clearance...
Risky Business
Aug 09, 2010
Caryn Silverman Evan Smith The Medical Device Safety Act of 2009 (MDSA)—H.R. 1346—was introduced by Representatives Frank Pallone Jr. (D...
Consider This A Warning
Jul 01, 2010
Marcarelli Cooper Helfgott Cochran Eleanor Roosevelt once said: “Learn from the mistakes of others. You can’t live long enough to...
How a 510(k) Submission Can Affect Your Patent
Jun 01, 2010
Regitz Dual disclosures to FDA and the U.S. Patent and Trademark Office (USPTO) that are not properly coordinated can sometimes have disastrous...